Regulatory Affairs Manager

Mô tả Công việc
1. Regulatory Strategy & Compliance
Develop and implement robust regulatory strategies to secure timely approval for new products and maintain existing product portfolios.
Monitor, analyze, and interpret changes in local and international regulations, assessing their potential impact on business operations and product pipelines.
Ensure all product formulas, labeling, packaging, and marketing claims strictly comply with relevant statutory guidelines and corporate policies.
2. Product Registration & Lifecycle Management
Oversee the preparation, compilation, and submission of high-quality regulatory dossiers for new product registrations, renewals, and variations.
Manage the lifecycle of product licenses and ensure timely renewals to prevent any disruption in supply chain or sales.
Coordinate with R&D, Quality Assurance, and Supply Chain teams to ensure technical documentation meets regulatory standards.
3. Stakeholder Management & Government Relations
Build and maintain strong, professional relationships with key regulatory bodies, government officials, and industry associations.
Represent the company in external regulatory forums, public consultations, and industry working groups to advocate for favorable regulatory environments.
Manage external consultants, scientific experts, and legal counsel when specialized regulatory support is required.
4. Team Leadership & Risk Management
Lead, mentor, and develop the Regulatory Affairs team, fostering a culture of high performance, compliance, and continuous learning.
Conduct proactive regulatory risk assessments and establish mitigation plans for product launches or formulation changes.
Provide timely regulatory guidance and training to cross-functional teams (Marketing, Sales, Legal, and Supply Chain).